INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II— 510(k) K012016

Substantially Equivalent

Siemens Medical Solutions USA, Inc.

FDA 510(k) clearance K012016 for INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II, Substantially Equivalent on 2001-07-20. Applicant: Siemens Medical Solutions USA, Inc..

Clearance details

Applicant: Siemens Medical Solutions USA, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2001-06-28
Decision date: 2001-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.